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Completed

NCT Number: NCT01260259

Seattle Cardiorenal Remote Ischemic Preconditioning Trial

Remote Ischemic Preconditioning (RIPC) is a treatment that may be associated with improved outcomes after cardiac surgery. It can be elicited noninvasively by using a tourniquet to elicit transient ischemia over a lower extremity. It is thought to promote anti-inflammatory and cell survival pathways, and thus protect remote organs against future ischemic injury. We hypothesize that compared to sham treatment, RIPC will be associated with decreased post-operative acute kidney, myocardial, and lung injury.

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Key information

Conditions

Congenital Heart Disease Acute Kidney Injury Acute Lung Injury Cardiopulmonary Bypass Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Defects, Congenital Heart Diseases Kidney Diseases Lung Diseases Lung Injury Male Urogenital Diseases Myocardial Injury Renal Insufficiency Respiratory Tract Diseases Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

About this study

In children undergoing cardiac surgery and cardiopulmonary bypass (CPB), our primary aims are to determine whether RPC is associated with: 1) decreased AKI and 2) decreased acute myocardial injury. Secondary aims include investigating the effects of RPC on post-procedure: 1)acute lung injury and 2) morbidity/mortality.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age birth to 18 years Cardiac surgery with planned cardiopulmonary bypass

Exclusion criteria

Any contraindication to compression of lower extremity/extremities Body weight <2 kg Active infection going into surgery On renal replacement therapy (RRT) or mechanical circulatory support going into surgery On inotropic support going into surgery

Treatment and study plan

RIPC

Procedure

RIPC will be elicited in the operating room (OR) after anesthesia induction and before start of surgery. After placement of an arterial line, a tourniquet will be placed over a lower extremity. It will be inflated to 15 mmHg above systolic blood pressure for 5 minutes, and then deflated for 5 minutes. This cycle of inflation-deflation will be repeated another 3 times before surgery.

Control

Procedure

In OR, after induction of general anesthesia and arterial line placement, a deflated tourniquet will be placed over the lower extremity for 40 minutes.

Primary outcomes

  1. Incidence of acute kidney injury (AKI)

    Time frame: 72 hours

    Serum creatinine (SCr) will be measured at baseline, then on post-operative days 1, 2, and 3.

  2. Incidence of acute myocardial injury

    Time frame: 48 hours

    Troponin-I will be measured at baseline, then 6, 12, 24, and 48 hours post-operative.

Secondary outcomes

  1. Incidence of acute lung injury

    Time frame: 72 hours and duration of hospitalization

    Days on mechanical ventilation, readiness for extubation.

  2. Hospitalization

    Time frame: Duration of post-operative hospitalization

    Number of post-operative days in cardiac intensive care unit (CICU) and hospital.

  3. Mortality

    Time frame: Duration of hospitalization, 30 days post-op, and at last follow-up

  4. Biomarkers for AKI

    Time frame: 72 hours

    Serum and urine will be collected for biomarker discovery.

  5. Inflammation

    Time frame: 72 hours

    Cytokines will be measured at baseline until 72 hours post-operative.

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Registry information

Official study title

Effect of Remote Ischemic Preconditioning in Children Undergoing Cardiac Surgery

Acronym: SCRIPT

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 15, 2010
Registry last updated
Sep 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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